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FDA 510(k)

APPLIED MEDICAL OPTICAL VALVULOTOME

K-Number: K945591 · 1995-02-10

ApplicantApplied Medical Resources
Decision Date1995-02-10
Product CodeLYK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

APPLIED MEDICAL OPTICAL VALVULOTOME is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Resources. It received FDA 510(k) clearance on 1995-02-10 under 510(k) number K945591. The device is classified under product code LYK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the APPLIED MEDICAL OPTICAL VALVULOTOME?

APPLIED MEDICAL OPTICAL VALVULOTOME is a medical device that received FDA 510(k) clearance on 1995-02-10. The listed applicant is Applied Medical Resources. The 510(k) number is K945591.

When did APPLIED MEDICAL OPTICAL VALVULOTOME receive FDA 510(k) clearance?

APPLIED MEDICAL OPTICAL VALVULOTOME received FDA 510(k) clearance on 1995-02-10, under 510(k) number K945591.

Who is the listed applicant for APPLIED MEDICAL OPTICAL VALVULOTOME?

The FDA 510(k) record lists Applied Medical Resources as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for APPLIED MEDICAL OPTICAL VALVULOTOME?

The FDA product code for APPLIED MEDICAL OPTICAL VALVULOTOME is LYK.

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Other records listing Applied Medical Resources as applicant

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Related Devices (Code: LYK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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